An innovative product development plan

Serum Institute found a way to manufacture the vaccine at a low cost. Photo: SIIL/S. Vinayak.

Passion for stopping meningitis inspired collaboration around the globe

In 2002, the Meningitis Vaccine Project (MVP) found a way to produce a conjugate vaccine at less than the price point African countries had identified as affordable: by partnering with the Serum Institute of India Ltd., a developing-country vaccine manufacturer.

With Serum Institute on board, the MVP team put together an innovative product development plan—where the raw materials came from one source, the technology from another, and the manufacturing capability from a third—to produce the meningococcal A conjugate vaccine MenAfriVac® at less than US$0.50 a dose.

Raw materials

PATH team members turned to the Serum Institute and Synco BioPartners in Amsterdam, the Netherlands, to supply the raw materials: the protein tetanus toxoid and the group A polysaccharide antigen. When the protein molecule is chemically joined with a polysaccharide antigen, it boosts the immunogenicity of the polysaccharide and creates a conjugate vaccine.

Conjugation technology

With the raw materials suppliers in place, the team next needed access to the conjugation technology—intellectual property that is valuable and highly protected. “This was not easy to resolve early on,” MVP director Dr. Marc LaForce said.

“Everyone believed in the mission.”

But a partnership with the Center for Biologics Evaluation and Research at the US Food and Drug Administration in Bethesda, Maryland, soon evolved. Dr. Robert Lee and Dr. Carl Frasch, two scientists at the center, had developed a new conjugation method that could be used. The project acquired the technology and, with help from the National Institutes of Health, transferred the technology within months to the Serum Institute at almost no cost.

“Everyone believed in the mission,” LaForce noted, crediting this collective passion for the relatively quick timeline of the project.

Passion

That same passion drove the Serum Institute to find a way to manufacture the vaccine at a low cost. Dr. S.V. Kapre, executive director of the Serum Institute, said the company was struck by the goal of creating a vaccine that would address a huge need in the developing world.

“Making a vaccine is a technical issue, but making the vaccine available at an affordable price is a real challenge,” Kapre said. Unless that challenge is met, the problem of meningitis won’t be solved because the people who need the vaccine won’t be able to afford it. So Serum made a conscious decision to be as frugal as possible to meet the vaccine price requirements, he said.